A CCEPTED MANUSCRIPT
Methods
Study design
This clinical trial was a single-site, randomized, double-blind, placebo-controlled, parallel-group,
proof-of-concept trial. The trial was conducted at the CRO Atlantia Food Clinical trials (Cork,
Ireland). The trial was conducted in accordance with the ethical principles set forth in the current
version of the Declaration of Helsinki, the International Conference on Harmonisation E6 Good
Clinical Practice (ICH-GCP). The trial was approved by The Clinical Research Ethics Committee of
the Cork Teaching Hospitals (Cork, Ireland) prior to trial conduct. The trial conduct period was July
– December 2017. The trial was registered at ClinicalTrials.gov under the ID number
NCT03228589.
Participants
MANUSCRIPT
All subjects were carefully informed about the trial before they signed the informed consent form
and were screened for participation criteria. Main inclusion criteria for participation were: Age
between 18 and 40 years, healthy and without GI symptoms, sedentary lifestyle and willingness to
refrain from other bacterial products and medication known to alter GI function throughout trial
participation.
Main exclusion criteria were: History of abdominal surgery (except appendectomy and
cholecystectomy), history of peptic ulcers, known bleeding disorders, known allergy to ASA,
history of diseases related to H. pylori infection, diastolic blood pressure ≥ 90 mmHg, systolic
blood pressure ≥ 140 mmHg, BMI > 27, smoking or use of other nicotine products, lactose
intolerance, pregnancy, lactation and regular use of probiotics, systemic antibiotics, steroids (except
contraceptives), NSAIDs, laxatives, anti-diarrheals, PPIs, and/or immunosuppressant drugs prior to
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